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Control strategy could facilitate faster bioburden detection
According to the paper, the control strategy for rapid bioburden testing provides manufacturers with enhanced capabilities for process control.
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Microbial Detection
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Mould study highlights safer far-UVC light cleaning alternative
Research suggests that to prevent common mould growth, low-dose far-UVC light could be applied as a chemical-free addition to manual cleaning of indoor surfaces.
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Pharma Horizons: Environmental Monitoring
This report is dedicated to exploring some of the latest advances in pharmaceutical environmental monitoring, covering topics from contamination control and cleanroom validation through to emerging technologies for bacterial endotoxin testing.
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Rapid pseudomonas aeruginosa detection method developed
Research suggests the rapid detection method “will enable the timely implementation of microbiological monitoring strategies for large batches of medications”.
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Preventing fungal contamination in pharmaceuticals
While fungal contamination detection in pharmaceutical manufacturing remains a challenge, preventive practices and policies must be followed, research states.
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Employing MALDI-TOF MS for microbial identification in sterile drug manufacturing
A study investigating microbial risks of the entire manufacturing process has identified MALDI-TOF MS as a promising first-line tool for pharmaceutical environmental monitoring.
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USP recommends revisions to proposed RMM chapters
Revisions for two proposed USP chapters recommend changes for rapid tests required for releasing sterile short-life products, as well as for rapid microbiological methods (RMM) for detecting contamination in these products.
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Rapid microbiology testing market to value nearly $13bn by 2034
Driven by a rise in infectious diseases and advancements in digital technologies, increased demand for rapid microbiology testing is set to accelerate the market’s growth.
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Biosensing technique promising for whole-genome detection
The bacterial detection method is robust and highly sensitive over a wide concentration range and does not require DNA amplification, research suggests.
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Will new therapeutic agent replace antibodies for bacterial detection?
Aptamers offer a “cutting-edge approach” for identifying gram-negative bacterial pathogens, a paper suggests.
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Bioburden and sterility testing: how to conserve gene therapy product
Here, Kathy Zagaroli, Senior Director of Quality Control at Kiniksa Pharmaceuticals, and Tom Bujold, Senior Director of Quality Control at REGENXBIO, discuss the challenges of bioburden and sterility testing for gene therapies and why industry must come together to drive increased harmonisation.
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Innovative technologies facilitate novel contamination-detection method
A new 24-hour sterility testing method combining nanopore sequencing and machine learning could revolutionise sterility assurance in biopharmaceutical manufacturing of cell therapies.
whitepaper
Application note: Equivalency of PCR-based rapid sterility testing and the compendial culture method
Sterility testing is a critical component of release testing for any cell therapy product since microbial contamination of cell therapy products can potentially kill recipients.
whitepaper
Whitepaper: The value and benefits of rapid mold detection in the pharmaceutical industry
Address the importance of accurate microbial identifications and proper contamination control for effective mold remediation.
whitepaper
Product hub: Rapid mold detection in as little as one day
Quick to spread and difficult to detect, molds can compromise a facility in the time it takes to confirm their presence. The RMBNucleusTM Mold Alarm signals at the first sign of mold detection.
